Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00040

2 Trial Registration Date

2005-09-08

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

CHAN Wai Man

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

CHAN Wai Man

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

vi Country

9 Official Scientific Title of the Study

A randomized controlled trial on the safety and efficacy of a modified regimen of photodynamic therapy with verteporfin on acute central serous chorioretinopathy

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-04-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Photodynamic therapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Observation

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: Aged 18 years or older VA with Snellen equivalent of d 20/200 Greatest linear dimension of the entire lesion with ICG-A guidance must not exceed 5400 £gm Exclusion criteria: On exogenous corticosteroid Systemic diseases such as Cushing¡¦s disease or renal diseases of glomerulonephritis Pregnancy Visual acuity worse than 20/200 in the affected eye Myopia </= -6.00 diopters, Presence of any choroidal neovascularization or other maculopathy Tear (rip) of the retinal pigment epithelium A history of laser photocoagulation Ocular surgery in the recent 3 months Any contraindication for the verteporfin infusion or fluorescein or ICG injection

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-10-01

21 Target Sample Size

62

22 Recruitment Status

Recruiting

23 Primary Outcome

Complete absorption of subretinal fluid

24 Secondary Outcome

electrophysiological results

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-16

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-08